EpicentRx BETA-PRIME Phase 1 Study Progresses After Demonstrating Good Safety & Tolerability
EpicentRx Inc. recently announced the initiation of the next stage of its Phase 1 trial, BETA-PRIME, with AdAPT-001, a TGF-beta (TGFß) trap-enhanced cancer targeting adenovirus. This milestone marks the successful completion of the first part of the Phase 1 trial in which nine patients were enrolled in a 3+3 dose escalation and evaluated for safety, tolerability, and optimal dose level of AdAPT-001. Based on favorable safety observations the study will transition to the next stage, enrolling additional patients at the highest evaluated dose of AdAPT-001 with treatment given every 2 weeks. This next stage of the trial will precede the final stage of the BETA-PRIME study in which a checkpoint inhibitor will be combined with AdAPT-001.
“We are very encouraged with the early safety and tolerability results seen in the first part of this Phase 1 study, and the clinical data is consistent with the favorable safety profile observed in preclinical studies,” said Tony R. Reid, MD, PhD, Chief Executive Officer of EpicentRx. “The patients we are enrolling in this study have resistant cancer which requires newer agents that are well-tolerated and attack the tumor in a non-traditional way. Our hope is that AdAPT-001 may prove to be that therapeutic option for these patients.”
TGFß, a protein that inhibits the activity of the immune system as a safeguard against severe inflammation and autoimmunity, is hijacked by cancer cells to escape immune elimination. Therapeutically resistant cancer is an area of high unmet medical need, which this triple combination strategy involving the AdAPT-001 cancer targeting virus armed with a TGFß trap and a checkpoint inhibitor intends to address.
AdAPT-001 is an oncolytic virus which is part of the company’s proprietary AdAPT Immunotherapy Platform, a platform developed on a genetically modified version of the human adenovirus, better known as the “common cold” that has been uniquely designed to preferentially infect and kill cancer cells. Currently in an ongoing Phase 1 trial for solid tumors, AdAPT-001 encodes a ligand trap comprised of the ligand-binding domain of the TGF-β receptor, which is fused to the portion of the human antibody known as the Fc domain.
EpicentRx is a clinical-stage biopharmaceutical company with a complementary pipeline of small molecules and cancer targeting virus platforms that represent the next frontier in treating patients with diseases of significant unmet need. With two platforms, CyNRGY and AdAPT, EpicentRx has developed therapies and novel drug delivery devices that fine tune the inflammatory response, turning it ON in cancer and turning it OFF in diseases like Alzheimer’s, Parkinson’s, and congestive heart failure, with emphasis on not just treating the disease but improving quality of life. For more information, visit www.epicentrx.com.
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